Medical Writer

DEPARTMENT: Clinical Operations
MANAGER: Vice President, Clinical Operations
LOCATION: San Diego, CA
TYPE: Consultant 

SUMMARY OF RESPONSIBILITIES: 

Aptose Biosciences is searching for a Medical Writer Manager (MWM) to support Clinical, Medical, & Research in San Diego, California. The MWM will collaborate with internal and external key team partners to develop clinical documents, abstract and publications that are aligned with the Company objectives.

PRIMARY RESPONSIBILITIES: 

  • Generate content in collaboration with authors/collaborators for protocols, investigator’s brochure, clinical study reports, safety updates, abstracts, posters, orals, manuscripts, and slide sets working from various data sources 
  • Performs Quality Control checking and proof reading of all required documents to meet customer expectation 
  • Manage multiple documents across different molecules/projects and obtain feedback from all key partners to define and implement documents strategies 
  • Appropriately communicates the scientific significance and value of all documents to the target audience, consistent with business processes and compliance requirements 
  • Understand and use product strategy, communication objectives, and lexicon appropriately to ensure alignment with publication content 
  • Maintain relationships with internal and external collaborators/authors on assigned documents and supports process improvement 
  • Understand the publication landscape (e.g., journals, congresses, readership) and advise key stakeholders accordingly 
  • Support documents and publication strategies and prioritization of documents and publications 
  • Drive documentation project timelines and handle multiple projects at a time; may support one or more products 
  • Ensure quality, alignment with objectives, and timely completion of publications while staying on track with allocated budgets

REQUIRED EDUCATION & WORK EXPERIENCE: 

  • PhD or Master’s degree and 3 years; OR 
  • Bachelor’s degree and 5 years, of clinical documentation and publication content development experience

PREFERRED QUALIFICATIONS: 

  • PhD, MD, or PharmD with at least 3 year of clinical documentation and publication development experience for industry in the bio-pharmaceutical sector 
  • Experience preparing clinical research documents, and manuscripts for publication in peer-reviewed medical journals as well as abstracts and posters or oral presentations for scientific congresses 
  • Experience working in a matrix team setting 
  • Experience collaborating with clinical investigator authors/collaborators on documents and publication development 
  • Exceptional analytical, communication, organizational, and interpersonal skills 
  • Ability to apply project management skills to advance numerous projects at a time and to deliver high-quality documents rapidly 
  • Ability to lead and/or facilitate effective team meetings for deliverables 
  • Proficient in word processing and pertinent software (e.g., Microsoft Office, EndNote) 
  • Knowledgeable about ICMJE (International Committee of Medical Journal Editors) and GPP3 
  • Good Publication Practices 3 guidelines 

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS: 

  • Knowledge of cGMP requirements for pharma / biotech industry 
  • Small molecule drug development 
  • Regulatory environment 
  • Process, procedures and best practices 
  • Proficient in Microsoft Office (Word, Excel, and Power Point) and Smartsheet 

COMPETENCIES: 

  • Attention to details 
  • Collaborate 
  • Communicate effectively in English, both oral and written 
  • Deliver on commitments 
  • Detail oriented and meticulous follow through 
  • Maintain composure 
  • Organizational skills 
  • Proactively plan and organize 
  • Solve problems 
  • Adapt 
  • Be self-aware 
  • Manage and improve process 
  • Facilitate 
  • Influence and persuade 
  • Lead

TRAVEL REQUIREMENTS: 

  • Up to 10%

Apply Now

Please fill out the form below to submit your application.

Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc